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Janet B. Serle, Gary D. Novack, Thomas J. Van Haarlem, Casey Kopczynski, AR-12286 Phase 2b Study Group; A 28-day Active-controlled, Phase 2b Study Assessing the Safety and Ocular Hypotensive Efficacy of AR-12286 in Patients with Elevated Intraocular Pressure. Invest. Ophthalmol. Vis. Sci. 2011;52(14):217.
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To evaluate the ocular hypotensive efficacy and safety of AR-12286 0.25% and 0.5% Ophthalmic Solutions in comparison to latanoprost in patients previously treated for ocular hypertension or glaucoma. AR-12286 is a selective Rho kinase inhibitor that lowers intraocular pressure (IOP) by increasing trabecular outflow.
Double-masked, active-controlled, randomized clinical trial. Subjects (n=217) were randomly assigned to receive AR-12286 0.25% b.i.d., AR-12286 0.5% q.d. PM, or latanoprost q.d. PM for 28 days. Primary and secondary efficacy endpoints were mean IOP at each diurnal time point (8 AM, 10 AM, 12 PM, and 4 PM) on days 14 and 28 and mean change in IOP from diurnal baseline, respectively.
Both concentrations of AR-12286 produced statistically and clinically significant reductions in mean IOP at all time points across days 14 and 28. Mean IOP ranged from 18.0 to 21.8 mm Hg (-6.0 to -3.9 mm Hg) for AR-12286 0.25% b.i.d., 18.0 to 20.4 mm Hg (-6.1 to -2.9 mm Hg) for AR-12286 0.5% q.d., and 17.5 to 19.0 mm Hg (-7.0 to -4.4 mm Hg) for latanoprost q.d. AR-12286 0.5% provided a superior diurnal IOP profile compared to AR-12286 0.25% due to better control of IOP at 8 AM (12 hours after PM dosing). The overall difference in mean diurnal IOP between AR-12286 0.5% and latanoprost was +0.9 mm Hg (p=0.002) in favor of latanoprost. This difference was +0.5 mm Hg (p=0.051) when responder sub-groups (mean IOP reduction >5%) were compared. The only adverse events of note for AR-12286 0.5% were conjunctival hyperemia, which typically resolved during sleep, and mild stinging upon instillation. Two out of 140 AR-12286 patients were discontinued for hyperemia (1 - 0.25%, 1 - 0.5%).
AR-12286 0.5% dosed q.d. PM provided better control of diurnal IOP than AR-12286 0.25% dosed b.i.d., was slightly less efficacious than latanoprost, and was well tolerated. There were no drug-related serious adverse events in the study.
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